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THERAPEUTIC GOODS ACT 1989 - SECT 32DE

Evaluation of biologicals

             (1)  If an application is made under section 32DD for a biological to be included in the Register in relation to a person, and the application has passed preliminary assessment, the Secretary must evaluate the biological for inclusion in the Register, having regard to:

                     (a)  whether the quality, safety and efficacy of the biological for the purposes for which it is to be used have been satisfactorily established; and

                     (b)  whether the presentation of the biological is acceptable; and

                     (c)  whether the biological conforms to any standard applicable to it; and

                     (d)  whether:

                              (i)  the applicable provisions of the Therapeutic Goods Advertising Code; and

                             (ii)  the other requirements (if any) relating to advertising applicable under Part 5-1 or the regulations;

                            are complied with in relation to the biological; and

                     (e)  if a step in the manufacture of the biological has been carried out outside Australia and the biological is not exempt from the operation of Part 3-3--whether the manufacturing and quality control procedures used in the step are acceptable; and

                      (f)  if a step in the manufacture of the biological has been carried out in Australia, the biological is not exempt from the operation of Part 3-3 and the person is not exempt from the operation of that Part in relation to that step--whether that step has been carried out in accordance with that Part; and

                    (fa)  if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)--whether, if the Secretary were to include the biological in the Register, the Secretary is satisfied that imports into Australia, exports from Australia or supplies in Australia of the biological would contravene those prohibitions; and

                    (fb)  if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions--whether, if the Secretary were to include the biological in the Register, the Secretary is satisfied that imports into Australia, exports from Australia or supplies in Australia of the biological would contravene those conditions; and

                     (g)  whether the biological contains substances that are prohibited imports for the purposes of the Customs Act 1901 ; and

                     (h)  whether all of the manufacturers of the biological are nominated as manufacturers of the biological in the application; and

                      (i)  such other matters (if any) as the Secretary considers relevant.

             (2)  For the purposes of paragraph (1)(e), subsections 25(2), (2E), (2F) and (2G) apply in a way corresponding to the way in which they apply for the purposes of paragraph 25(1)(g).



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